Senior Regulatory Affairs Lead — Remote

Cardinal Health, Inc.; Atlanta (GA); Remote; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. seeks a Regulatory Affairs professional to support regulatory submissions for pharmaceuticals, biologics, and devices from discovery through post-approval maintenance.

The role includes authorship/review of eCTDs for US and outside-US Health Authorities, regulatory strategy support, and ensuring NDA/ANDA/MAA/DMF compliance. Collaboration across cross-functional teams and with regulators is essential.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry.
• Bachelor's degree or equivalent; Advanced degree desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, T-con, emails).
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR parts and guidance.
• Prior work with European drug applications preferred.
• Excellent verbal and written communication skills; experience authoring technical documents.

Responsibilities

• Authorship and/or review and oversight of creation of eCTDs for drug submission to US and outside-US Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with conditions of approval of NDAs, ANDAs, MAAs and NDSs.
• Oversee and perform risk management reviews through products' life cycles and participate in change management processes.
• Provide regulatory guidance for manufacturing sites, CMOs, and contract laboratories.
• Managing communication with regulatory agencies and representing the company as required.
• Participate in cross-functional teams and vendor meetings as assigned.

Skills

Regulatory affairs

Education

Bachelor's degree or equivalent

Advanced degree desirable

Tools

eCTD software

Job description

Cardinal Health, Inc. seeks a Regulatory Affairs professional to support regulatory submissions for pharmaceuticals, biologics, and devices from discovery through post-approval maintenance.

The role includes authorship/review of eCTDs for US and outside-US Health Authorities, regulatory strategy support, and ensuring NDA/ANDA/MAA/DMF compliance. Collaboration across cross-functional teams and with regulators is essential.